Successful Phase III PIONEER II study of Humira for Hidradenitis Suppurativa- AbbVie

AbbVie announced new results from PIONEER II, a pivotal Phase III study, demonstrating the effect of Humira (adalimumab) in reducing common clinical signs and symptoms in moderate-to-severe Hidradenitis Suppurativa (HS), specifically the number of abscesses and inflammatory nodules. Data were presented as a late-breaking abstract at the 23rd Congress of the European Academy of Dermatology and Venereology (EADV) meeting in Amsterdam.

The results of this study, in combination with previously presented results from PIONEER I, will contribute to worldwide regulatory filings for an expanded use of HUMIRA. Results from the PIONEER II study found that at 12 weeks, patients with moderate-to-severe HS treated with HUMIRA 40 mg weekly, beginning at week 4 (after HUMIRA 160 mg at week 0 and 80 mg at week 2), achieved a statistically significant greater response compared to those on placebo (58.9 percent versus 27.6 percent, p<0.001). Response was defined as an improvement of HS related abscesses and inflammatory nodules at 12 weeks using the Hidradenitis Suppurativa Clinical Response (HiSCR) measure. This is defined as at least 50 percent reduction from baseline in total abscess and inflammatory nodule (AN) count with no increase for either abscess or draining fistula count.

HS, sometimes referred to as "acne inversa" by dermatologists, is a chronic skin disease characterized by inflamed areas typically located around the armpits, groin, on the buttocks and under the breasts.